Clinical Trials Office SOPs
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CCCTO SOP Glossary of Common Terms & Definitions **Working Document**
1. Administrative SOPs
1.1. SOP on SOPs **Posted 3/4/13**
1.2. Change Management SOP **Posted 3/25/13**
1.3. Organizational SOP
1.4. Education/Training
1.5. Notifications
2. Study Selection
2.1. Identify Protocols
2.1.1. CDA
2.1.2. Feasibility
2.2. Select Protocols
2.2.1. Research Manager Review
2.2.2. Faculty Disease Committee Review
2.2.3. Scientific Review Committee
3. Study Feasibility
3.1. Develop/Process Contracts
3.2. Budget/Logistics Development
3.2.1. Study calendar creation
3.2.2. Standard of care/research determinations
3.2.3. Pricing
3.3. Ancillary Committees
3.4. Gather/Develop Site Documentation
4. Study Setup
4.1. Logistic Finalization
4.1.1. Required protocol training **Posted 5/8/13**
4.1.2. Site initiation visits
4.1.3. Clinicaltrials.gov submission/updating
4.1.4. IND Application
4.2. IRB Submissions
4.2.1. New submissions
4.2.2. Emergency Use Protocols
4.2.3. Compassionate Use Protocols
4.3. Accounting
5. Study Conduct
5.1. Notification of Study Opening to Enrollment
5.2. Pre-screening
5.3. Patient Screening & Enrollment
5.4. Schedule Services
5.5. Research Billing Management
6. Ongoing Processes
6.1. Study Monitors & Monitoring Visits **Posted 3/25/13**
6.2. Regulatory
6.2.1. Amendments
6.2.2. CPRs
6.2.3. Reportable Events
6.2.4. External Safety Reports – Industry Sponsored **Posted 3/25/13**
6.2.5. External Safety Reports – Cooperative Groups **Posted 3/25/13**
6.2.6. General
6.2.6.1. Uploading study documents in Oncore
6.2.6.2. Regulatory document preparation & retention
6.2.6.2.1. Completing the 1572 & Financial Disclosures **Posted 5/8/13**
6.2.6.2.2. Completing the Delegation of Authority Log **Posted 5/8/13**
6.2.6.2.3. Regulatory document retention
6.3. Clinical Research Coordinators
6.3.1. Randomizing a patient
6.3.2. Recording patient visits
6.3.3. Locating Current IRB Approved Protocol Documents
6.3.4. Consent forms
6.3.5. Data Entry/CRF Completion
6.4. Principle Investigators
6.4.1. Financial disclosures, etc. timelines
6.5. General
6.5.1. Audit Preparation
6.5.2. Internal Audits
6.5.3. External Audits
6.5.4. Planned Study Transition Between CTO Employees
6.5.5. CTO Employee Resignation
6.5.6. Use of Care Everywhere in Epic for Clinical Trials **Posted 5/20/13**
7. Study Closure
7.1. Closing a study to enrollment
7.2. Notification of Study Closure to Accrual